altona Diagnostics today announced the launch of the RealStar® Bundibugyo Virus RT‑PCR Kit 1.0 (RUO), a dedicated real-time RT-PCR assay for specific detection of Bundibugyo virus RNA to support filovirus research and outbreak-related investigation workflows. The launch comes in response to the ongoing Ebola disease outbreak caused by Bundibugyo virus in the Democratic Republic of the Congo and Uganda, which the World Health Organization (WHO) has declared a Public Health Emergency of International Concern (PHEIC). 1
On 15 May 2026, Bundibugyo virus was confirmed as the causative agent of the current Ebola disease outbreak in both countries2, underscoring the need for rapid deployment of molecular tools that can support laboratories and outbreak-response partners. From internal project decision to first production lot, altona Diagnostics completed development of the new RealStar® Bundibugyo Virus RT‑PCR Kit 1.0 (RUO, 96 reactions) in only six days, building on its existing Bundibugyo-specific assay components and filovirus test portfolio.
The new assay extends altona’s established filovirus product range, which already includes the RealStar® Filovirus Screen RT-PCR Kit 1.0 (available as CE‑IVD and RUO) for qualitative detection and differentiation of Ebola- and Marburgvirus-specific RNA, and the RealStar® Filovirus Type RT-PCR Kit 2.0 (RUO) for qualitative detection and differentiation of filovirus RNA including five Ebolavirus species, among them Bundibugyo ebolavirus. These products have been referenced in published evaluations and outbreak reports as tools capable of detecting the currently circulating Bundibugyo virus variant.3
By focusing the Bundibugyo-specific amplification system into a 96‑reaction RUO format, the RealStar® Bundibugyo Virus RT-PCR Kit 1.0 provides a targeted option for laboratories that already have comprehensive strategies in place for screening and typing filoviruses and now require increased testing capacity specifically for the Bundibugyo virus. The new kit can be used within altona’s AltoStar® Molecular Diagnostic Workflow as well as on many open real-time PCR platforms, enabling integration into existing laboratory infrastructures.
“With this dedicated Bundibugyo assay, we are extending our contribution to filovirus outbreak preparedness by giving laboratories an additional, focused tool that complements broad filovirus screening and typing,” says Juliana Peters, the altona Diagnostics Product Manager for filovirus assays. “Our rapid development timeline shows what is possible when existing molecular expertise is aligned with urgent public health needs.”
altona Diagnostics continues to supply its filovirus assays to partners in the Democratic Republic of the Congo, Uganda, and other regions via direct shipments, international organizations, and a network of distribution partners, under export-control conditions. The company has adjusted production capacity for its filovirus product line to help maintain availability for reference laboratories, research centers, and outbreak-response stakeholders.
The new RealStar® Bundibugyo Virus RT‑PCR Kit 1.0 is for research use only. It is not for use in diagnostic procedures. Users are responsible for appropriate validation in their laboratories and for compliance with applicable local regulations before use as a laboratory-developed test.
For further information on altona’s filovirus outbreak-preparedness portfolio, including assays for Ebola and Bundibugyo virus detection, visit the dedicated info page on the altona Diagnostics website: Outbreak preparedness
altona Diagnostics is a medical diagnostic company that develops and manufactures in vitro diagnostic tests for the PCR based detection of pathogens such as viruses, bacteria, or parasites. Headquartered in Hamburg-Altona, Germany, altona Diagnostics is privately owned and employs more than 350 people worldwide, thereof 300 in Hamburg, Germany. The company has been in the molecular diagnostics business for over 25 years and is ISO 13485 certified. altona Diagnostics sells its registered products to medical laboratories globally through subsidiaries and more than 40 distribution partners.
Molecular diagnostic tests from altona Diagnostics are based on real-time PCR technology. altona Diagnostics offers the AltoStar® Molecular Diagnostic Workflow, an automated solution that is complete with instrumentation, reagents, consumables, and software. Furthermore, the company’s product catalog contains over 50 CE marked PCR tests that are also compatible with open real-time PCR platforms.
For further information, please contact: | |
| Meike Thiel | Phone: +49 (0)40 5480676-0 |
| altona Diagnostics GmbH | Fax: +49 (0)40 5480676-10 |
| Mörkenstr. 12 | info@altona-diagnostics.com |
| 22767 Hamburg, Germany | www.altona-diagnostics.com |
For further information, please contact:
Meike Thiel
altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany
Phone: +49 (0)40 5480676-0
Fax: +49 (0)40 5480676-10
Release date: 2026-06-04
Release date: 2026-06-04
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